Team Lead - Engineering (Process Mechanical)

Job Summary This role is for an Engineering Operations and Maintenance Manager, responsible for overseeing the operation, maintenance, and continuous improvement of critical utility and process systems—including mechanical equipment, HVAC, WFI, PW, steam, and instrumentation—across the facility.

The position ensures regulatory compliance, safety adherence, and system reliability through robust preventive, predictive, and reliability-centered maintenance strategies.

Key responsibilities include leading engineering projects, managing CAPEX budgets, coordinating with cross-functional departments, and ensuring timely execution of equipment modifications, calibrations, and validations.

The role also focuses on energy conservation, cost optimization, and maintaining audit readiness through effective documentation and quality systems. " Roles & Responsibilities Oversee the operation and maintenance of critical engineering systems—including mechanical equipment, HVAC, WFI, PW, and steam—to ensure continuous availability and optimal performance.

Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, managing documentation, and implementing corrective and preventive actions using tools like Why-Why analysis, Kaizens, and Poka-yoke.

Lead engineering projects from initiation to completion, including resource planning, budget estimation, vendor coordination, and timely execution of instrumentation modifications.

Develop and monitor preventive maintenance schedules in SAP, execute calibrations as per SOPs, and improve maintenance practices to reduce equipment breakdowns.

Coordinate with cross-functional departments such as SHE, QA, QC, Production, IT, and Finance to ensure seamless maintenance and utility service delivery.

Drive energy efficiency and cost optimization by implementing conservation techniques, monitoring utility generation costs, and maintaining records of energy consumption.

Mentor and train engineering teams on maintenance procedures, safety protocols, hazard identification, and compliance with work permit requirements.

Prepare and execute equipment qualification and validation schedules—including URS, DQ, IQ, OQ, PQ—and ensure documentation accuracy through cross-functional collaboration. "

Educational Qualification Graduation in Mechanical Engineering or related field is mandatory.

Minimum Work Experience 10+ years of experience.

Skills & Attributes Functional Skills Alarm Management Design Modification Human Machine Interfaces Instrumentation Machinery Repair and Maintenance Failure Analysis Predictive Maintenance Programmable Logic Controllers Resident Skills Audit Management Current Good Manufacturing Practices (cGMPs) Lean Methodologies Total Productive Maintenance Behavioural Skills Execution excellence – ensures timely delivery of engineering projects and maintenance activities with precision and accountability.

Compliance leadership – upholds regulatory standards through rigorous audits, documentation, and proactive risk mitigation.

Team stewardship – builds a high-performing engineering team through coaching, training, and a culture of safety and continuous improvement.

Critical Exposures 5+ years of experience in roles across Engineering / Mechanical / Utilities domain in pharmaceutical manufacturing is desired.

Experience in maintaining and upgrading mechanical equipment like reactors, dryers, high pressure vessels and pumps is desired.

Experience in ensuring compliance with cGMP, QMS, EHS, and other regulatory standards in mechanical systems is desired.

Experience in ensuring uptime and reliability of HVAC and water systems interfaced with mechanical equipment is desired.

Exposure to automation and control systems for mechanical operations, including PLC-based controls, SCADA, and IoT-enabled predictive maintenance tools is preferred. "